This invention relates generally to surgical appliances and more specifically to a device for anchoring various types of surgical tubes, such as gastrostomy tubes painlessly, efficiently and economically.
Generally, patients who are unable to eat after having undergone certain surgical procedures, or who are unable to eat due to certain medical conditions, are supplied nutrients through a tube known as a "gastrostomy tube." It is necessary to anchor the gastrostomy tube, so that it does not pull out of the patient while the patient moves, or is moved during bathing, sheet changing, etc. Presently, practitioners use several methods to keep the tube from pulling out of the body. In each case, the tube is inserted into the stomach through an incision in the abdomen made by a procedure known as a "gastrostomy". To prevent the tube from pulling out of the body, a Foley (balloon), Malecot (batwing) or Pezzar (mushroom) catheter is inserted. Each of these devices is a unitary tube/catheter device.
It is also necessary to minimize relative movement between the tube and the incision site, because any movement causes ulceration of the site. The tube may still, however, flop around, because it is not confined in its inclination to the body. Prior to our invention, certain methods have been used. Each of those methods, described below, has drawbacks. All of the methods described below, in addition to our method, aim to secure the tube against side to side movement in addition to movement out of the patient's body.
One method used is to wrap a substantial amount of suture thread around the tube, forming a collar several inches from the incision. Suture strands are then anchored to the tube, by looping and tieing under the collar. The other end of each suture strand is then sutured to the patient's skin. This procedure is repeated at several locations around the circumference of the tube. Afterwards, the tube is taped to the skin several inches beyond the point of attachment of the sutures. The result is that the tube is secured in an upright position, resembling a radio transmission tower secured by guy wires, or the support structure of a tent. This method is painful and irritating to the patient, whose skin is constantly being tugged this way and that by the sutures piercing it.
Another method incorporates a plastic, stepped, accordian pleated sleeve and a pectin and polymethylcellulose wafer of the type used as part of a wafer and pouch system for containing effluent after surgical diversion of the intestine or bladder, in procedures such as nephrostomies. The tube/catheter unit is inserted into the body through the incision and anchored by activating the catheter as described above. Next, the tube is fed through the sleeve. The narrow opening of the sleeve faces away from the body and the wide end touches the body. The pectin wafer is placed over the sleeve, with the tube passing through a round hole in the center of the wafer. The sleeve is intended to secure the tube, but in practice, the sleeve is too flexible to provide the support necessary to immobilize the tube. Further, it is impossible to inspect or clean the incision site, without removal of the anchoring device, because it is covered by the pectin wafer and plastic sleeve. Cleaning is very important because of the risk of infection. Further, secretions trapped under the wafer irritate the skin.
Another method has been discussed using a pectin wafer of the type described above fitted with a flange (of the type sold by Squibb and Company under the trade name "Stomahesive Wafer with Sur-Fit Flange"), using a piece of durable suture and the screw-on cap of a baby bottle, having a hole in its face. The wafer is applied with the tube protruding through the opening. One inch above the incision, a length of 1-0 silk suture is tied to the tube tightly enough so that it will not slide. The thread is positioned so that it lies along the surgical tube to the center of the wafer and then out across the rim of the flange. The tube is passed through the hole in the baby bottle lid which is then snapped inside the flange, with the thread secured between the edge of the lid and the rim of the flange. The suture facilitates removal of the bottle lid, for access to the insertion site for inspection, cleaning and reinforcement of the wafer as it erodes. This method does not provide sufficient vertical support of the tube and requires the step of tieing and positioning the thread. The incision is not visible or accessible for cleaning without removing the bottle lid. Due to the tenderness of the site, any unnecessary movement and irritation is to be avoided.
Finally, a method similar that described above with respect to the bottle lid, employs a baby bottle nipple. This method has been described in the JOURNAL OF ENTEROSTOMAL THERAPY, Vol. 10, pp. 108-110 (1983). According to this method, the wafer is applied as above, and the tube is threaded through a nipple with the end snipped off. A convex insert ring of an appropriate size fits concentric with the nipple, and anchors the nipple to the flange, by snapping under the flange. The nipple then supports the tube. A drawback of this method are that the nipple is too flexible to support the tube. Further, it is not possible to examine and clean the incision site with the nipple in place. Finally, the flexible nipple and concentric ring assembly is complicated to install and remove.
Among the several objects of our invention is to provide an apparatus for the secure support of a gastrostomy or similar tube, without causing unnecessary pain to the patient. Another object of the invention is to provide such a support which is easy to install and remove, and which permits cleaning of the incision site without removal of the device. Another object of the invention is to provide such a support which permits inspection of the insertion site while the support device is in place. Yet another object of the invention is to provide a system of securing gastrostomy or similar tubes, which system may be easily adapted to secure tubes of various sizes and shapes. A final object is to provide a tube anchoring device and system simple to use that family members can attend to this aspect of the patient's care at home.